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Posts Tagged: "viagra"

Merck and Pfizer Downgrades on Patent Cliff Concerns Signal Importance of Patents to Pharma

Last month, business news outlets were reporting that stock prices for pharmaceutical firms Pfizer and Merck took a tumble after financial analysts downgraded the performance of both firms over concerns about impending patent cliffs or exclusivity issues – although more recent reports paint a mostly promising picture for the companies, thanks to upcoming acquisitions. A pharmaceutical analyst for UBS downgraded Pfizer from buy to neutral, citing the loss of patent protection in the 2025 to 2029 timeframe for several drugs which contributed 30 percent of Pfizer’s total revenue in 2015. For Merck, although patent expiry wasn’t cited in a note from a pharmaceutical analyst from BMO, that analyst dropped Merck’s rating from outperform to market perform based on the expectation that the company’s blockbuster cancer drug Keytruda would face increased competition in the immuno-oncology field during 2019. As of January 30, stock prices for both firms were down by at least a dollar per share from their closing price on January 23. The downgrades for both firms are further proof of the importance of maintaining exclusivity through patent protection to pharmaceutical firms.

What happens when lifestyle drugs like Viagra and Cialis lose patent protections?

Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their erectile dysfunction (ED), but they may not be the only ones facing dysfunctionalities. As the patents on these lucrative lifestyle drugs come to an end, price tags and bottom lines are expected to plummet… The lifestyle drug market is extremely lucrative. These medications can be used by all age groups worldwide and increased individual awareness of health and beauty has created a demand for physical fitness and improved performance of all our body parts. People are living longer, have higher disposable income, and the demand only grows more when a drug touts the high quality and safety of their formulations after it passes the stringent requirements for FDA approval… The real question, however, is whether U.S. patent law and policy will continue to give pharmaceutical companies the incentives necessary to innovate lifesaving medicines, or whether we will continue to see more and more blockbuster lifestyle drugs moving into the future.

The Need for Regulatory Data Protection in the TPP: Why Australia’s Got it All Wrong

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.

Biotech and Pharma Update: News for December 2013

What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of December 2013. Fitch Puts Negative Outlook on Bristol-Myers. AstraZeneca Loses at the Federal Circuit on Omeprazole. Merck and GlaxoSmithKline Collaborate on Regimen for Advanced Renal Cell Carcinoma. Teva and Pfizer Settle Viagra® Patent Dispute. FTC Settles with Mylan over Agila Acquisition. FDA Fast Tracks Savara Pharmaceuticals Antibiotic AeroVanc to treat MRSA. Fitch Gives Johnson & Johnson AAA Rating. Sales of Antiretroviral Drugs for HIV Predicted to Decrease.

Northern Exposure: Pfizer Canada’s Viagra® Patent Invalidated

The Supreme Court of Canada rendered a decision on November 8, 2012 effectively canceling Viagra® Canadian patent a year and a half before its natural expiration date. This ends Pfizer’s exclusivity on the blockbuster erectile disfunction drug and opens the market up to generics. While certainly a press- worthy event, this decision does not change the Canadian patent landscape – but rather reinforces it.

Pfizer’s Erectile Dysfunction Claim for Viagra® Found Invalid

In the opinion, the BPAI agreed with the reexamination Examiner that any one of four (out of five) prior art references that contained descriptions of oral administration of the herb Yin Yang Huo (also known, perhaps not too surprisingly, as horny goat weed) are anticipatory prior art for claim 24. There were other rejections (double patenting rejections) that the Examiner set forth and that BPAI upheld. The patent claims cover the first commercially (wildly) successful male impotence drug Viagra®.